Indocyanine Green Fluoroscopy and SPY Angiography for the Assessment of Lymphatic Structure in Breast Cancer Patients at Risk for Breast Cancer-Related Lymphedema

Summary

This clinical trial assesses the change in lymphatic structure from placement of an intravenous (IV) line and fluid administration using a diagnostic agent, indocyanine green (ICG), with SPY (Trademark) angiography in breast cancer patients at risk for breast cancer-related lymphedema (BCRL). Patients that are diagnosed with breast cancer with lymph node involvement often undergo treatment that includes surgery to remove the axillary nodes and radiation. Unfortunately, this procedure increases the incidence of BCRL in the surgical arm, as well as other problems including heaviness of the arm, fibrotic skin changes, and an increase in infection risk. Because of these symptoms, venipuncture (blood draw) is often avoided in these arms. Researchers want to show that placement of an IV line and fluid administration in patients at risk for BCRL will indeed not alter the lymphatic structure of the arm and will not change the incidence of BCRL by administering indocyanine green (ICG) dye to patients and assessing their arm lymphatics. ICG is a fluorescent dye that is able to be visualized by the SPY angiography imaging system as it travels through the lymphatic system, allowing researchers to assess how well blood flows throughout the body. Receiving ICG and undergoing SPY angiography may be effective in showing that placement of an IV and fluid administration in breast cancer patients at risk for BCRL will not alter the lymphatic structure of their arm and will not change the incidence of BCRL.

Conditions

• Breast Cancer-Related Lymphedema
• Breast Carcinoma

Interventions

PROCEDURE

Fluid Therapy

Given IV

DRUG

Indocyanine Green

Given subcutaneously

OTHER

Questionnaire Administration

Ancillary studies

OTHER

Research or Clinical Assessment Tool

Undergo lymphedema assessment

PROCEDURE

SPY Elite Fluorescence Imaging

Undergo SPY imaging

OTHER

Survey Administration

Ancillary studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Jeff Chang · City of Hope Medical Center

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-14

Primary Completion

2026-08-14

Completion

2026-08-14